Two-year prospective single-arm multicenter study results of clinical safety and performance of synthetic ParieteneTM DS composite mesh in ventral hernia repair
DOI:
https://doi.org/10.18203/2349-3259.ijct20261376Keywords:
Ventral hernia, Primary hernia, Incisional hernia, Hernia repair, Polypropylene mesh, Synthetic meshAbstract
Background: In ventral hernia surgery, using synthetic meshes is the standard of care to provide additional support to weakened or damaged tissues. This study aimed to assess clinical safety and performance of the synthetic Parietene™ DS composite mesh in ventral hernia repair.
Methods: This is a prospective, single-arm, multicenter study including adults undergoing intraperitoneal onlay mesh repair for ventral hernias using Parietene™ DS composite mesh. Patients were enrolled at 6 US sites and evaluated at discharge and 1, 3, 12, and 24 months postoperatively. Primary endpoint was hernia recurrence at 12 months; secondary endpoints included hernia recurrence at 1, 3 and 24 months, adverse device effects and patient quality of life (QoL). Surgeon satisfaction with mesh was also assessed.
Results: A total of 125 patients were included in this study: 70 treated for primary hernias and 55 for incisional hernias; 68 patients underwent laparoscopy, 56 robotic and 1 open surgery. Only 4 (3.3%) hernia recurrences were reported, all within 12 months. No additional recurrences occurred at 24 months. No significant differences were found in hernia recurrence incidence between hernia type or surgery approach sub-groups. No adverse events related to mesh were reported. Patients experienced significant improvement in QoL at 12- and 24-month post-surgery compared to baseline and 1 month. For >95% of procedures, surgeons rated handling, deployment, and introduction of the mesh as easy or very easy.
Conclusions: Parietene™ DS composite mesh use in ventral hernia repair assures a safe profile, low hernia recurrence rate and improvement in patient QoL.
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